Software as a Medical Device (SaMD): Regulatory & Quality Perspectives

This course, Software as a Medical Device: Regulatory and Quality Perspectives, establishes a clear understanding of what qualifies as SaMD and how global regulatory bodies evaluate software intended for medical purposes. The course provides a comprehensive framework for assessing, developing, and documenting SaMD in alignment with major regulatory authorities.

Key topics covered include:

• Foundational Concepts: Establishing the IMDRF definition of SaMD and clarifying global regulatory interpretations.
• Global Regulatory Frameworks: Detailed examination of the U.S. FDA perspective and the EU MDR framework (focusing on Rule 11 for software classification).
• Quality Systems: Reviewing SaMD lifecycle expectations, integration with quality systems (including IEC 62304 and ISO 14971 risk management), and addressing critical cybersecurity requirements.
• Emerging Considerations: Exploring AI and machine learning-enabled SaMD, including the FDA’s Total Product Lifecycle approach.

By the end of the course, you will progress from foundational knowledge to advanced regulatory application, applying these concepts through practical classification exercises and case studies.